We are internationally recognized as experts in advanced aseptic processing and risk-based isolation and barrier technologies. Our experience, awareness and understanding of industry trends places importance on time-to-market, plant flexibility and cost control to avoid costly project delays and minimize risk.
300+ Years of Combined Aseptic Processing Experience
Worldwide Aseptic Design Capabilities; Successfully Completed Aseptic Projects on 5 Continents; Placed over $3B in Aseptic Capital Projects
Breadth of Experience: Quality, Engineering, Aseptic Production, Packaging, Maintenance, Validation, Development and Regulatory
Strategic Business Planning for Advanced Aseptic Processing
Compliance Risk Evaluations and Assessments
Outstanding Relationships with Respected Aseptic Processing Equipment Vendors
Using Sterile Enclosure Technology for OEL Containment and Performing Aseptic Manipulations such as liquids into nested syringes
Experienced in the application of FDA, EU Annex 1, Canada, China, Japan, Brazil and World Health Organization Regulations and Guidance
Designed and Upgraded over 20 Filling / Capping Lines to meet EU Annex 1 guidance.
Advanced Aseptic Team of Subject Matter Experts who Lecture Worldwide and Contribute to Prominent Industry Publications
Knowledge of State-of-the-Art Advanced Aseptic, RABS and Isolation/Barrier Technologies
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